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This biweekly newsletter provides concise, independent coverage and analysis of fast-breaking lab, pathology, blood banking, imaging and diagnostic radiology news from the Nation's Capital.
You'll find out about:
- Medicare payment and policy directives Billing guidelines and coding changes for diagnostic facilities
- CLIA & MQSA regulatory mandates, changes and interpretations
- Congressional actions & legislative initiatives
- Federal compliance requirements
- OIG anti-fraud initiatives
- Stark self-referral prohibitions
Plus you will get other legal news regarding FDA oversight of in vitro diagnostics, blood banks, and radiological devices OSHA, NRC, and state safety standards.
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 | NIR April 14, 2008 (full PDF issue) |
| Gains in proficiency testing pass rates reported by CLIA cytology program
CMS enjoined from enforcing anti-markup rules on certain anatomic pathology arrangements
Dissecting the court’s injunction to stop the Medicare lab bidding demo for now—see the Focus
—Flaws found in demo design
—Major challenges in lawsuit upheld; others not subject to judicial review
—Irreparable harm real, not speculative ACLA urges CMS to rethink coverage and payment policy for new panel code 80047
OIG changes payment rules for advisory opinions
Washington Watch: House approves genetic anti-discrimination provisions, sends bill to Senate
Full Article |
| House Approves Overhaul of CLIA Cytology Proficiency Testing |
| The House on Apr. 8 approved by voice vote a bipartisan bill that would revamp the CLIA program for proficiency testing in gynecologic cytology, a measure backed by a coalition of more than 60 organizations, including national and state pathology groups.
Full Article |
| Court Orders Halt to Medicare Lab Competitive Bidding Demo |
| A federal court issued a preliminary injunction Apr. 8 that blocks the Centers for Medicare & Medicaid Services from moving ahead with the lab competitive bidding demonstration in San Diego County until further notice.
Full Article |
| Preliminary Injunction Granted in Pathology Anti-Markup Lawsuit |
| A federal court on Mar. 31 ordered a preliminary injunction barring the Centers for Medicare & Medicaid Services from enforcing anti-markup rules that apply to anatomic pathology diagnostic services furnished in a centralized building, as defined in the Stark physician self-referral law. The court said the injunction is in force "until trial on the merits of the case or further notice."
Full Article |
| CLIA Cytology Program Shows Gains in PT Pass Rates |
| While the CLIA program for proficiency testing in gynecologic cytology is highly controversial, it has registered major gains in the passing scores of pathologists and cytotechnologists since nationwide enforcement began in 2005, according to the Centers for Medicare & Medicaid Services.
Full Article |
| Court Grants Preliminary Injunction Halting Lab Bidding Demo |
| Three clinical laboratories in the San Diego area that are suing to stop the Medicare competitive bidding demonstration in their locale won an important victory on Apr. 8 when a federal court granted their request for a preliminary injunction to bar the project from going forward until further notice.
Full Article |
| ACLA to CMS: 'Rethink Policy on New Panel Code' |
| The American Clinical Laboratory Association has asked the Centers for Medicare & Medicaid Services to change its coverage and payment policy for the new CPT code 80047, Basic metabolic panel (ionized calcium). In a Mar. 14 letter to CMS, ACLA also said the panel should not be considered an ESRD composite rate test.
Full Article |
| Washington Watch (0804a) |
| Prospects for passage this year of prohibitions to protect Americans from genetic discrimination by employers and insurers depend on Senate action, now that the House has approved these prohibitions and sent them to the Senate as part of a broader measure, H.R. 1424.
Full Article |
| OIG Changes the Payment Rules for Advisory Opinions |
| If you want advice from the HHS Office of Inspector General about kickback and other legal risks to your current or proposed business arrangement, you no longer must put down a $250 deposit. Instead, you will pay the costs of preparing an advisory opinion in one lump sum directly to the U.S. Treasury via electronic funds transferÐÐchecks and money orders will no longer be accepted. Once the OIG gets confirmation of payment in full, you will get the opinion.
Full Article |
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